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Digene Diagnostics

This article was originally published in The Gray Sheet

Executive Summary

Receives approvable letter from FDA for its HPV Profile, a DNA probe test for "the 14 oncogenic and non-oncogenic types" of human papillomavirus, the Silver Spring, Maryland-based company reports. The test has two "cocktails" -- one detects nine HPV DNA types (16, 18, 31, 33, 35, 45, 51, 52 and 56) that have been linked to cervical cancer, and the other detects five types (6, 11, 42, 43 and 44) that "rarely, if ever" are associated with cancer, according to Digene. HPV Profile does not identify the specific type of HPV DNA present but provides results in the form of a risk profile -- either high/intermediate risk, low risk or negative. Digene currently offers ViraType, which detects seven types of HPV DNA in three groupings -- types 6 and 11, types 16 and 18 and types 31, 33 and 35 -- and ViraPap, which does not distinguish between types of HPV DNA
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